# CRA II - Germany - client dedicated

**Company**: Syneos Health
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/CRA-II---Germany---client-dedicated_25113121?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_998dcbae-9c1

## Description

Syneos Health is seeking a CRA II to work in Germany. As a CRA II, you will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits

- Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions

- Verify process of obtaining informed consent has been adequately performed and documented for each subject/patient

- Assess factors that might affect subject/patient's safety and clinical data integrity

- Conduct Source Document Review of site source documents and medical records

- Verify required clinical data entered in the case report form (CRF) is accurate and complete

- Apply query resolution techniques remotely and on site

- Utilize available hardware and software to support effective conduct of clinical study data review and capture

- Verify site compliance with electronic data capture requirements

- Perform investigational product (IP) inventory, reconciliation, and reviews storage and security

- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness

- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents

- Support subject/patient recruitment, retention, and awareness strategies

- Enter data into tracking systems as required

- Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met

- Act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate

- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings

- Provide guidance at the site and project level towards audit readiness standards

- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes

Qualifications:

- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Previous monitoring experience in Germany

- Fluency in both German and English

- Excellent communication, presentation, and interpersonal skills

- Ability to manage required travel of up to 75% on a regular basis

Benefits: Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- German
- English
- Clinical Monitoring

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/CRA-II---Germany---client-dedicated_25113121?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)